Strengthening the Informed Consent Process in International Health Research through Community Engagement: The KEMRI-Wellcome Trust Research Programme Experience

1. MolyneuxCSPeshuNMarshK 2004 Understanding of informed consent in a low-income setting: three case studies from the Kenyan Coast. Soc Sci Med 59 2547 2559

2. FloryJEmanuelE 2004 Interventions to improve research participants' understanding in informed consent for research: a systematic review. JAMA 292 1593 1601

3. MarshallPAAdebamowoCAAdeyemoAAOgundiranTOVekichM 2006 Voluntary participation and informed consent to international genetic research. Am J Public Health 96 1989 1995

4. CorneliALBentleyMESorensonJRHendersonGEvan der HorstC 2006 Using formative research to develop a context-specific approach to informed consent for clinical trials. J Empir Res Hum Res Ethics 1 45 60

5. MarshallPA 2008 “Cultural competence” and informed consent in international health research. Camb Q Healthc Ethics 17 206 215

6. MolyneuxCSPeshuNMarshK 2005 Trust and informed consent: insights from community members on the Kenyan coast. Soc Sci Med 61 1463 1473

7. MolyneuxCSWassenaarDRPeshuNMarshK 2005 ‘Even if they ask you to stand by a tree all day, you will have to do it (laughter)…!’: community voices on the notion and practice of informed consent for biomedical research in developing countries. Soc Sci Med 61 443 454

8. GikonyoCBejonPMarshVMolyneuxS 2008 Taking social relationships seriously: lessons learned from the informed consent practices of a vaccine trial on the Kenyan Coast. Soc Sci Med 67 708 720

9. MolyneuxCGoudgeJRussellSChumaJTebogaG 2009 Conducting heatlh-related social science research in low income settings: Ethical dilemas faced in Kenyan and South Africa. Journal of International Development 21 309 326

10. MarshVKamuyaDMlambaAWilliamsTNMolyneuxS 2010 Experiences with community engagement and informed consent in a genetic cohort study of severe childhood diseases in Kenya. BMC Med Ethics 11 13

11. MarshVKamuyaDRowaYGikonyoCMolyneuxS 2008 Beginning community engagement at a busy biomedical research programme: experiences from the KEMRI CGMRC-Wellcome Trust Research Programme, Kilifi, Kenya. Soc Sci Med 67 721 733

12. LidzCWAppelbaumPS 2002 The therapeutic misconception: problems and solutions. Med Care 40 V55 V63

13. AppelbaumPSRothLHLidzCWBensonPWinsladeW 1987 False hopes and best data: consent to research and the therapeutic misconception. Hastings Cent Rep 17 20 24

14. MarshVMKamuyaDKParkerMJMolyneuxCS 2011 Working with concepts: the role of community in international collaborative biomedical research. Public Health Ethics 4 26 39

15. NCST 2005 Guidelines for ethical conduct of biomedical research involving human subjects in Kenya Nairobi National Council for Science and Technology

16. CIOMS 2002 International ethical guidelines for biomedical research involving human subjects. Available: http://www.cioms.ch/publications/guidelines/guidelines_nov_2002_blurb.htm Accessed 10 August 2011

17. GCP 2010 International conference on harmonisation of technical requirements for registration of pharmaceuticals for human use: good clinical practice. Available: http://ichgcp.net/. Accessed 4 August 2011

18. CTN Clinical Trials Network Best Practices, Duke Clinical Research Institute. Informed consent document templates & instructions. Available: https://www.ctnbestpractices.org/resources/study-patient-management/informed-consent/templates-forms/. Accessed 4 August 2011

19. National Health Service 2002 Information sheets and consent forms: guidance for researchers and reviewers London National Patient Safety Agency – National Research Ethics Service, National Health Service Available: http://www.nres.npsa.nhs.uk/applications/guidance/consent-guidance-and-forms/. Accessed 4 August 2011

20. Office of Human Subject Research 2006 Guidelines for writing informed consent documents Bethesda Office of Human Subject Research, NIH Available: http://ohsr.od.nih.gov/info/info.html. Accessed 4 August 2011

21. WHO 2010 Informed consent form templates Geneva WHO Available: http://www.who.int/rpc/research_ethics/informed_consent/en/. Accessed 4 August 2011

22. MilfordCWassenaarDSlackC 2006 Resource and needs of research ethics committees in Africa: preparations for HIV vaccine trials. IRB 28 1 9